Tuesday’s Tidbits

SCOTUS

Tuesday’s Tidbits

David Ermer–COVID-19, FDA, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the FEHB front, Federal News Network provides an update on the GAO report on FEHB that was mentioned in yesterday’s post.

The Office of Personnel Management, the agency that runs the health insurance program for federal employees and retirees, does not have a clear way to identify and remove FEHB enrollees’ family members who are erroneously part of the program, according to the Government Accountability Office.

“The longer OPM delays its efforts to establish a monitoring mechanism to identify and remove ineligible members from FEHB, the more ineligible members and related improper payments in the program may continue to accrue, costing the program millions, or up to approximately one billion dollars per year, according to OPM’s own estimate,” GAO said in a Jan. 9 report.

OPM said it has received the final report and is planning to flesh out a larger response soon.

OPM’s Healthcare and Insurance Office “will be evaluating potential action items, including timelines, and will provide a comprehensive response to GAO within 180 days upon evaluation of the recommendations,” OPM spokesperson Viet Tran told Federal News Network.

From the public health front,

January is Cervical Cancer Awareness Month, and Patient Engagement HIT tells us

Nearly one in 10 women have never had a common cervical cancer screening, like a Pap test, with issues such as limited health literacy and poor access to care getting in the way, according to a Harris Poll conducted on behalf of BD (Becton, Dickinson and Company).

These trends are more common in racial minorities, with Black and Hispanic women being more likely to say they have never had a Pap test. Compared to the 6% of White women who said they’ve never had a Pap test, 12% of Hispanic women and 13% of Black women said the same. * * *

receipt of Pap tests is extremely low, the survey of 872 women ages 18 to 64. Overall, 71 percent of respondents have delayed getting a Pap test, with 15 percent saying their last OB/GYN check-up was three years ago.

Although not explicitly explored in the survey, it’s key to note that timeline aligns with the outbreak of the COVID-19 pandemic when access to primary and preventive care stalled. * * *

The good news is, around three-quarters of all respondents, regardless of race, said they have resolved to get back on track with their primary and preventive care, including Pap tests and HPV screenings, in the new year.

But doing so will require some leg work from the healthcare industry, which should note some patient health literacy and convenient care access snags getting in the way.

Even though nearly every respondent said they are knowledgeable about women’s health (91 percent), a whopping 81 percent admitted they don’t know how often they should get a Pap test and 51 percent said they were unaware of how often they should get an HPV test.

The survey also found consumer support for an at-home screening test. Kaiser Permanente and MD Anderson Center offer their views on at-home screening, and MD Anderson reminds us

The best protection for both men and women against HPV and related cancers[, i.e. cervical cancer,] is the HPV vaccine. All males and females ages 9-26 should get the HPV vaccine. It is most effective when given at ages 11-12. Unvaccinated men and women ages 27-45 should also talk to their doctor about the benefits of the vaccine.

MedPage Today reports

Adhering to healthy eating patterns was associated with lower risk of total and cause-specific mortality, a prospective cohort study with up to 36 years of follow-up showed.

Among 75,230 women from the Nurses’ Health Study and 44,085 men from the Health Professionals Follow-up Study, those who scored in the highest quintile for healthy eating patterns recommended by the Dietary Guidelines for Americans (DGAs) had a 14% to 20% lower risk of total mortality versus those in the lowest quintile, reported Frank Hu, MD, PhD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Internal Medicine opens in a new tab or window.

The pooled multivariable-adjusted hazard ratios of total mortality with four healthy eating patterns were (P<0.001 for trend for all):

  • Healthy Eating Index 2015 (HEI-2015): HR 0.81 (95% CI 0.79-0.84)
  • Alternate Mediterranean Diet (AMED): HR 0.82 (95% CI 0.79-0.84)
  • Healthful Plant-Based Diet Index (HPDI): HR 0.86 (95% CI 0.83-0.89)
  • Alternate Healthy Eating Index (AHEI): HR 0.80 (95% CI 0.77-0.82)

This lower risk was consistent across all racial and ethnic groups.

NIH’s NIAAA Director provides tips for a successful dry January. Good luck to all those who made this resolution because

Taking a break from alcohol for an entire month provides one with an opportunity to assess their patterns of alcohol consumption and how it affects them physically and mentally. It gives a person a chance to cultivate alternatives for relaxing, socializing, and coping with stress. As a result, many people experience benefits such as improved sleep and waking without the fatigue, malaise, and upset stomach of a hangover. Some also find that without the extra calories due to alcohol they lose weight. Participants in Dry January also describe positive effects on their relationships. And an added bonus is saving money.

STAT News brings us up to date on mpox.

From the Omicron and siblings front,

  • Becker’s Hospital Review provides some geographic details on the current winter’s Covid surge.
  • The National Institutes of Health announced “The antiviral treatment Paxlovid reduced the risk of hospitalization or death from SARS-CoV-2 Omicron variants in older adults by 44%. Wider use of Paxlovid may help temper a winter surge of COVID-19, as some other treatments are no longer effective.”
  • Politico reports on progress being made to end the Covid public health emergency later this year.

From the Food and Drug Administration front,

  • STAT News interviews the FDA Administrator Robert Califf on the Congressional investigative report concerning the Aduhelm fiasco.
  • The FDA announced that “In 2022,  the Center for Drug Evaluation and Research approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in our annual New Drug Therapy Approvals report. We also approved drugs in new settings, such as for new uses and patient populations.” 

From the Rx coverage front, Drug Channels delves into major prescription benefit manager formulary exclusions lists for 2023.

From the medical research front, the National Institutes of Health announced, “Researchers developed a blood test that could detect Alzheimer’s disease-promoting compounds in the blood long before symptoms emerged. The findings may lead to early diagnostic tests for Alzheimer’s and other neurodegenerative diseases.”

From the U.S. healthcare business front

  • Fierce Healthcare’s lead article on the ongoing JP Morgan healthcare conference concerns CVS’s Heath’s foray into primary care.
  • Healthcare Dive adds, “CVS Health is exploring an acquisition of value-based primary care chain Oak Street Health, according to a Monday Bloomberg report. The two are in ongoing talks and could reach a deal within weeks that values Oak Street at more than $10 billion including debt, according to Bloomberg, which cited sources familiar with the matter a deal.”
  • Healthcare Dive informs us that “Teladoc Health shared an early look at its financial results at JPMorgan’s healthcare conference on Monday, indicating between $633 million and $640 million in revenue for the fourth quarter, a little higher than consensus estimates from analysts. The virtual care giant projected total 2022 revenue between $2.4 billion and $2.41 billion, according to its regulatory filing. Teladoc’s direct-to-consumer mental health unit, BetterHelp, is expected to contribute roughly $1 billion of that topline.”
  • STAT News reports, “Rising labor costs have been the main financial concern for hospitals over the past year, but those costs have peaked and are now a lot lower, according to hospital system executives who presented during the J.P. Morgan Healthcare Conference.”

From the post-Dobbs front, STAT News tells us about telehealth provider reactions to the Justice Department’s announcement last week permitting abortion drugs to be sold by mail and the FDA’s opportunity for pharmacies to sell those drugs.

From the Supreme Court front, STAT News relates

The U.S. Supreme Court rejected a bid by Pfizer to use a copay-assistance program to help Medicare beneficiaries pay for an expensive heart drug. The company argued the program would not violate kickback laws, a controversial issue that forced numerous drugmakers to pay large fines. Last July, an appeals court panel upheld a lower court ruling that such programs would violate federal law, but Pfizer filed a petition to the Supreme Court that contended such interpretations are “staggeringly overbroad.” Pfizer maintained there was no “corrupt intent” in offering assistance and that Medicare beneficiaries would be denied needed medicines they would otherwise not be able to afford.

It’s up to Congress to fix this problem.

Happy Independence Day

David Ermer–Congress, COVID-19, SCOTUS–

Congress is on a State / District work break this week.

The Supreme Court ended its October 2021 Term last week by recognizing retiring Justice Stephen Breyer and Judge Ketanji Brown Jackson was sworn in as the 104th Associate Justice of the Supreme Court last Thursday, June 30.

From the Omicron and siblings front –

Bloomberg Prognosis reports on New York City’s significant improvements to its test to treat program.

New York City will start offering Pfizer Inc.’s Covid antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus.

Initially [last Thursday June 30], mobile sites will be stationed outside of pharmacies in Inwood, South Ozone Park and the East Bronx, and will expand to 30 locations by the end of July, Manhattan’s Borough President Mark Levine said on Twitter Thursday. People who test positive for Covid and qualify for Paxlovid will be able to get a prescription on-the-spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.

“We were the epicenter of the Covid pandemic at the start, but we’re leading the way in prevention and mitigation,” [NYC Mayor Eric] Adams said during the press conference. “What we’re doing here other cities can look at to make a determination of how they want to address Covid.”

Bloomberg adds “Earlier on Thursday, Pfizer asked US regulators for full approval of Paxlovid for people at high risk of developing severe disease, bringing the drugmaker one step closer to securing a formal clearance that would allow it to sell and market the antiviral outside of the public health emergency.”  

The Wall Street Journal helpfully tells us

Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. According to an updated list of expiration dates, it may still be good. 

The Food and Drug Administration has extended the expiration dates for some authorized at-home, over-the-counter Covid test kits in recent months, meaning some unused tests may still be viable. 

Many Americans received free tests from the federal government this year. They also bought their own tests, especially at the height of the first Omicron wave that hit much of the country over the winter.

While the FDA initially marked many at-home Covid-19 kits with a fairly short shelf life, additional data gathered since then from manufacturers has given the agency more insight into how long the tests can be used accurately. 

The article also includes a Q&A.

Precision Vaccines wonders when the FDA will consider granting emergency use authorization to the traditionally developed Covid vaccine from Novovax.

Monday Roundup

David Ermer–CDC, Congress, COVID vaccine mandate, COVID-19, Medicare, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Federal News Network discusses the federal employee pay raise angles presented by the House financial service and general appropriations bill which cleared the House Appropriations Committee last Friday. Federal News Network indicates that the bill leaves the door open for the Senate to also accept the President’s proposed 2023 4.6% pay raise for federal employees and the military.

From the Dobbs case front, Govexec.com reports

President Joe Biden announced two actions immediately after the ruling: one directing the Department of Health and Human Services to safeguard access to contraception and medication abortion, and another protecting travel for medical appointments.

To those ends,

  • Govexec tells us that OPM today confirmed that its policy allowing federal employees to apply sick time to travel out of state remains in effect after the high court struck down Roe v. Wade, and
  • The Department of Health and Human Services (HHS) announced that a meeting was held today between Affordable Care Act regulators, including the HHS and Labor Department Secretaries, and health plan executives to emphasize the importance of full compliance with the ACA’s contraceptive coverage with no cost-sharing mandate when delivered in-network. The ACA regulators also issued a letter to health plans making the same point.

The FEHBlog ran across this NPR Shots article which explains that the Plan B or morning-after pill is considered a contraceptive and not an abortion drug. The Wall Street Journal informs us

Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.CVS Health Corp.,  Walmart Inc., and Rite Aid Corp. were limiting purchases of the pills, which were in short supply or out of stock Monday morning on major retailer websites. CVS and Rite Aid were limiting purchases to three. Walmart had some pills available without limits, but only in cases where they wouldn’t ship until next month. Pills available this week were limited to four or six.

From the Omicron and siblings and monkeypox front

  • Govexec reports on a U.S. Court of Appeals for the Fifth Circuit decision order rehearing a federal employee vaccine mandate case which upheld the mandate on lack of plaintiffs’ standing to challenge the mandate. The mandate nevertheless has remained on hold while the case winds it way through the appellate court.
  • USA Today reports on when and how to access the monkeypox vaccine.

From the Medicare front, HHS announced

a new model aimed at improving cancer care for Medicare patients and lowering health care costs. CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) designed the Enhancing Oncology Model (EOM) to test how to improve health care providers’ ability to deliver care centered around patients, consider patients’ unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs.

From the reports and studies department —

  • The next issue of Health Affairs offers a bevy of articles on Type 2 diabetes and pre-diabetes which are available at this link.
  • The Congressional Budget Office has made available examples of the work performed by its Health Analysis Division.
  • HealthDay reports “More than 18 million Americans have now survived cancer, a new report shows. The American Cancer Society (ACS) and the U.S. National Cancer Institute collaborated on the report to estimate cancer prevalence and help public health officials better serve survivors.”
  • mHealth Intelligence calls our attention to a telehealth-oriented  Healthcare Experience Report: 2022 released by Zocdoc. The FEHBlog was pleased to read “Mental health continues to hold a place of dominance in telehealth. In May of 2020, 2021, and 2022, the percentage of mental health visits that occurred virtually was 74 percent, 85 percent, and 87 percent, respectively.” Hub and spoke telehealth, e.g, Teladoc, brings mental health care in-network thereby lowering benefit costs while improving access to care.

Friday Stats and More

David Ermer–Congress, COVID-19, Federal employment benefits, OPM, SCOTUS, U.S. Healthcare, Uncategorized–

Note — Unfortunately, Thursday’s post did not arrive on the E&S website until 9 am ET today, so it did not go out to subscribers this morning. Lo siento. Here is a link to yesterday’s post.

Onto today’s post —

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases:

The CDC’s weekly review of its Covid statistics states “As of June 22, 2022, the current 7-day moving average of daily new cases (97,430) decreased 5.6% compared with the previous 7-day moving average (103,175).”

Here’s the CDC’s weekly chart of new Covid hospital admissions:

The CDC’s weekly review states “The current 7-day daily average for June 15–21, 2022, was 4,375. This is a 1.0% increase from the prior 7-day average (4,329) from June 8–14, 2022.”

Here is the FEHBlog’s latest weekly chart of new Covid deaths:

The CDC’s weekly review states “The current 7-day moving average of new deaths (255) has decreased 10.4% compared with the previous 7-day moving average (285).”

The CDC’s weekly review also reports

As of June 23, 2022, there are 391 (12.1%) counties, districts, or territories with a high COVID-19 Community Level, 996 (30.9%) counties with a medium Community Level, and 1,830 (56.8%) counties with a low Community Level. This represents an increase (+1.9 percentage points) in the number of high-level counties, a slight increase (+1.6 percentage points) in the number of medium-level counties, and a corresponding decrease (−3.6 percentage points) in the number of low-level counties. 51 jurisdictions had high- or medium-level counties this week. Rhode Island is the only jurisdiction to have all counties at low Community Level. 

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

The weekly statistics generally are stable and moving in the right direction.

The American Hospital Association adds

The Centers for Disease Control and Prevention last night endorsed Moderna’s COVID-19 vaccine for children aged 6-17, as its advisory committee recommended, creating an alternative to Pfizer’s COVID-19 vaccine for this age group. The Food and Drug Administration authorized the Moderna vaccine for children and adolescents last week.

Before ACA FAQ 50 issued October 4, 2021, the period for covering COVID vaccines with no cost sharing began 15 days after the CDC’s action. The FEHBlog, who is not errorless, thought that FAQ 50 eliminated the 15 day waiting period, but upon further review, FAQ 50 requires immediate no cost sharing coverage of Covid vaccines filing the FDA’s approval, usually an emergency use authorization. The FEHBlog doesn’t think this makes any practical difference because the Covid vaccines aren’t distributed without CDC approval.

From the Capitol Hill, the American Hospital Association provide us with this encouraging news:

The House of Representative today voted 234-193 to pass and send to the President for his signature bipartisan legislation to help reduce gun violence in communities. Approved by the Senate last night, the AHA-supported package includes behavioral health provisions, including funding for school safety resources, school-based supportive services and expanded access to telehealth for mental and behavioral health services. 

From the Supreme Court, the Court decided today that the right to an abortion is a matter controlled by state law, not the U.S. Constitution. The Wall Street Journal sums it up as follows “In upholding a Mississippi law banning the procedure after 15 weeks of pregnancy, the court’s conservative majority said the Roe decision was egregiously wrong in recognizing a constitutional right to abortion.” In response

Reproductive health care, including access to birth control and safe and legal abortion care, is an essential part of your health and well-being. While Roe v. Wade was overturned, abortion remains legal in many states, and other reproductive health care services remain protected by law. The U.S. Department of Health and Human Services (HHS) is committed to providing you with accurate and up-to-date information about access to and coverage of reproductive health care and resources. Our goal is to make sure you have appropriate information and support.

  • Health Payer Intelligence discusses health insurer reaction to the decision. “Payers and healthcare leaders are responding to the Supreme Court’s decision to overturn Roe v Wade, the case which protected abortion rights at the federal level, and while the repercussions remain uncertain many healthcare leaders are voicing their commitment to helping women navigate the impacts.”
  • The Wall Street Journal discusses employer reaction to the decision. “Businesses with health plans covering abortion now are weighing whether and how to pay for employees to travel to a state where the procedure is legal.”

From the OPM front

  • Federal News Network reports on OPM Director Karen Ahuja’s press conference held yesterday, the first anniversary of her swearing in as OPM Director.
  • FedWeek tells us that “OPM has said it is working to improve features for federal employees and annuitants to compare FEHB plans, although it does not project having those improvements in place until late next year—potentially in time for that year’s open season for selecting coverage in 2024.”

From the nicotine front, the Wall Street Journal reports

A federal appeals court on Friday granted Juul Labs Inc. a temporary stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.

A panel of judges from the U.S. Court of Appeals for the D.C. Circuit on Friday afternoon granted Juul’s request to delay the FDA’s ban, according to court documents. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.

Finally, HR Dive brings us a roundup of happenings at this week’s Society for Human Resource Management conference.

Happy First Day of Summer 2022

David Ermer–AHRQ, CDC, Congress, COVID-19, Electronic health records, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here. 

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

Midweek update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, HSA, SCOTUS, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Capitol Hill, Medtech Dive reports

The Senate Committee on Health, Education, Labor and Pensions voted Tuesday to send a bill to the Senate that would reauthorize the Food and Drug Administration to collect user fees from device- and drug-makers for the next five years. 

A provision would require the FDA to finalize guidance that would create a category of over-the-counter hearing aids within a month of the bill’s passage. The FDA last issued a proposed guidance in October.

Committee Ranking Member Sen. Richard Burr, R-N.C., questioned on Tuesday whether the FDA should have that expanded authority, despite co-sponsoring legislation that would change how diagnostic tests are regulated, including laboratory-developed tests.

Fierce Healthcare adds

The American Hospital Association (AHA) penned a last-ditch letter to congressional leaders pleading for Medicare sequester cuts slated to take effect July 1 to be halted in light of the financial strain many of the nation’s hospitals are expected to face throughout 2022.

Congress had initially paused the 2% payment cut as part of the CARES Act when the COVID-19 pandemic began to threaten providers’ bottom lines. Sequestration cuts were continually punted downfield until last December, when a bill was signed to resume a 1% cut in April and the full 2% in July.

With half a month to go, AHA Executive Vice President Stacey Hughes warned majority and minority leaders Tuesday that financial relief from the pending cut is necessary for hospitals “to maintain access to care for the patients and communities they serve.”

From the Supreme Court, the American Hospital Association gleefully informs us

The U.S. Supreme Court today ruled unanimously in favor of the AHA and others, reversing a 2020 [U.S.] court of appeals decision upholding the authority of the Department of Health and Human Services to significantly cut payments to certain hospitals that participate in the 340B Drug Pricing Program, and thereby threatening access to care for patients.

The Supreme Court held that “HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were contrary to the statute and unlawful.” Noting that “340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support,” the Supreme Court observed that “this case has immense economic consequences, about $1.6 billion annually.”

Despite those serious practical impacts, the Supreme Court concluded that “[u]nder the text and structure of the statute,” the case is “straightforward” as a matter of law: “Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.”

From the Omicron and siblings front —

The Wall Street Journal reports

Health experts advising U.S. health regulators backed giving Covid-19 vaccines from Pfizer Inc. and BioNTech SE and from Moderna Inc. to children as young as 6 months old. 

The panel voted 21 to 0 in a pair of votes on Wednesday in support of expanding access to the vaccines.

The positive recommendations will likely lead soon to expanding the U.S. Covid-19 vaccination campaign to the 19.6 million children from 6 months to under 5 years of age, one of the last groups of people in the U.S. waiting for shots.

The Food and Drug Administration, which doesn’t have to follow the panel’s recommendations but usually does, is expected to authorize the shots within days. Vaccinations could begin as early as June 21, according to the Biden administration.

and

Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date.

The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September.

BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months.

STAT News adds

Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations.

Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid.

The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid. But the results, published in a press release, are likely to take time for experts to digest and understand.

From the unusual viruses front, the American Hospital Association explains

The Centers for Disease Control and Prevention yesterday [June 14] updated its guidance to help clinicians evaluate and test patients with relevant history, signs and symptoms for monkeypox. Over 1,800 monkeypox or orthopoxvirus cases have been reported globally this year, including 72 in the United States. According to CDC, the virus does not spread easily between people without close contact, so the risk to the general population remains low.

The World Health Organization plans to change monkeypox’s name next week.

From the healthcare business front

Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it’s also launching new brands for two of its subsidiaries.

The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word “care” with the suffix “lon,” which means full or complete, representing the company’s ambition to offer an end-to-end care experience.

Carelon will include Anthem’s in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.

and

Humana is moving its pharmacy brands under the CenterWell umbrella.

Humana Pharmacy and Humana Specialty Pharmacy will now operate as CenterWell Pharmacy and CenterWell Specialty Pharmacy, respectively, the insurer announced. Enclara Pharmacia and Humana Pharmacy Solutions, the company’s pharmacy benefit management arm, will maintain their original branding.

“The CenterWell brand symbolizes our ongoing and strong commitment to keeping members, customers and patients at the center of everything we do,” said Scott Greenwell, Humana Pharmacy Solutions president, in a statement.

  • Morning Consult discusses how CVS Health and Walgreens retained “high customer trust” in 2021.

From the benefit design front, Employee Benefits News offers the case for health savings accounts. The FEHBlog is already sold.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, SCOTUS, Telehealth, U.S. Healthcare–

Congress is back on Capitol Hill this week for floor voting and Committee business. Roll Call notes

Lawmakers return next week for a busy June, with Senate Republicans tested by politically wrought gun talks and President Joe Biden dealing with a spate of crises and headaches.

The Hill identifies the five “looming disputes” out of 33 pending disputes that the Supreme Court is expected to decide this month which typically is the last month of its October 2021 Term. Although not found among the Hill’s cases, here’s a Medicare secondary payer act case that has not been decided yet and could impact FEHBP.

Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., No. 20-1641 [Arg: 03.1.2022 Trans./Aud.] 

Issue(s): (1) Whether a group health plan that provides uniform reimbursement of all dialysis treatments observe the prohibition provided by the Medicare Secondary Payer Act that group health plans may not “take into account” the fact that a plan participant with end stage renal disease is eligible for Medicare benefits; (2) whether a plan that provides the same dialysis benefits to all plan participants, and reimburses dialysis providers uniformly regardless of whether the patient has end stage renal disease, observe the prohibition under the Medicare Secondary Payer Act that a group health plan also may not “differentiate” between individuals with end stage renal disease and others “in the benefits it provides”; and (3) whether the Medicare Secondary Payer Act is a coordination-of-benefits measure designed to protect Medicare, not an antidiscrimination law designed to protect certain providers from alleged disparate impact of uniform treatment.

From the Omicron and siblings front —

The Wall Street Journal reports

The latest Covid-19 wave in the U.S. has shifted westward, hitting places like the San Francisco area, while pressure eases in recent Northeast hot spots.

The Western U.S. region, which includes mountain and coastal states, has recently eclipsed the Northeast to have the nation’s highest rate of known cases per 100,000 people, a Wall Street Journal analysis of CDC data shows. Recent increases in parts of the West come amid declines in the Northeast.

NPR Shots provides more background on the Novovax Covid vaccine that the FDA advisory committee will consider for emergency use authorization this Tuesday. NPR Shots adds

The federal government is trying to decide what kind of booster people should get in the fall to try to blunt the severity of a possible new wave of infections next winter. The panel of FDA advisers will meet late this month to consider which strains of the coronavirus should be targeted by updated vaccines.

From the mental health coverage front, the American Hospital Association released a TrendWatch about the pandemic’s adverse impact on mental health. Also, Healthcare Dive informs us that while telehealth use dropped in February and March 2022, according to a Fair Health study,

Teletherapy continued to remain robust, snagging the top procedure spot for telehealth visits in March and representing 26% of virtual claim lines, the report noted. Mental health conditions claimed 65% of diagnoses across all regions. Likewise, social workers remained the most popular specialty in telehealth claims for the second month in a row.

From the value-based care front, Health Payer Intelligence discusses how payers can move providers away from fee-for-service contracts to value-based contracts. It’s worth a read.

Monday Roundup

David Ermer–ACA, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

The President has declared May 1 through May 7 to be Public Service Recognition Week. OPM explains

Celebrated annually during the first week of May since 1985, Public Service Recognition Week (PSRW) (external link) is time set aside to honor the men and women who serve our nation as federal, state, county and local government employees. 

Throughout the country, mayors, governors, agency leaders, communities and public service organizations participate in PSRW by issuing proclamations; hosting award ceremonies and special tribute events; and delivering messages about the value of public service.

To that end, Govexec reports the President took the time today to virtually award Presidential Rank Awards to 230 senior federal employees from 37 agencies.

Speaking directly to the career civil service, Biden said: “Over the last 15 months you’ve helped us deliver so much to the American people,” such as the getting Americans vaccinated against COVID-19, delivering economic relief checks, caring for veterans, implementing the infrastructure package and working to restore the public’s faith in government and democracy. He gave a big “thank you” to them as well as their families. 

The FEHBlog heartily agrees.

From the Omicron and siblings front, WebMd informs us

The FDA’s independent panel of advisors will meet in June to discuss the Pfizer and Moderna COVID-19 vaccines for children under age 5, as well as the Novavax vaccine for adults, according to an FDA announcement released Friday.

On June 7, the FDA’s vaccine committee will review the Novavax shot, which could become the first new COVID-19 vaccine to hit the U.S. market in more than a year. The shot is already authorized in more than three dozen countries, including across Europe.

The FDA has also selected three possible dates — June 8, 21, and 22 — to discuss the shots for kids under age 5. The dates are tentative because the companies haven’t completed their submissions, the agency said.

The FEHBlog is pleased to read about these developments because the Novovax shot which uses a traditional vaccination approach may be acceptable to the vaccine inquisitive and the country needs a vaccine for younger children.

STAT News adds

Pfizer released news late Friday that Paxlovid, the antiviral currently subject to a big push from the U.S. government, failed to prevent people living with Covid patients from catching the infection.

The news is one of several bad headlines for the new Covid pill, but one experts say doesn’t affect the medicine’s primary use: treating people who are already sick.

Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital, said he would “absolutely” prescribe Paxlovid to people at high risk of severe disease who have Covid. “Without hesitation,” he said. “Because the net benefit in the high risk study was extremely high.”

From the Affordable Care Act front, Health Affairs Forefront has posted the second part of Katie Keith’s three-part series on last week’s HHS final 2023 notice of ACA benefit and payment parameters. The second part concerns changes specific to the ACA marketplace or exchange plans.

From the Rx coverage front, Health Affairs informs us

UnitedHealthcare is restricting insurance coverage of Aduhelm across all of its health plans, saying the drug “is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to the company’s new policies.

Physicians who plan on giving Aduhelm to UnitedHealthcare patients will need to obtain prior approval from the insurance company, effective June 1. Patients also need to be in an approved clinical trial.

UnitedHealthcare’s decision follows Medicare, which said last month it would only pay for the costly infusion drug for patients who participate in a clinical trial. UnitedHealthcare is the largest Medicare Advantage insurer in the country, covering 8 million people older than 65 and people with disabilities, making this policy particularly important for older Americans on those private plans.

The FEHBlog expects UHC’s announcement to be the tip of the eventual iceberg of similar Aduhelm coverage decisions.

Following up on previous stories mentioned in the FEHBlog, the Wall Street Journal reports

Online pharmacy company Truepill Inc. said it is temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder, and partner Cerebral Inc. told its clinicians to direct those orders to patients’ local pharmacies.

Cerebral, an online mental-health company based in San Francisco that describes Truepill as its preferred pharmacy, informed its clinicians of Truepill’s decision in a Friday email viewed by The Wall Street Journal. The email said Truepill would no longer support mailing Schedule 2 controlled substances, including Adderall and Vyvanse, “to any of their customers.”

Truepill said that, “out of an abundance of caution,” it is temporarily pausing all fulfillment of Schedule 2 substances while it evaluates appropriate next steps. It said Schedule 2 substances such as Adderall make up less than 1% of its total prescription volume. Truepill didn’t provide a list of other partners affected by its decision.

Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the past year from clinicians working for telehealth startups that have sprung up to treat ADHD, according to pharmacies and people familiar with the issue.

The Journal reported last week that pharmacies including Walmart Inc., CVS Health Corp. and Walgreens Boots Alliance Inc. have blocked or delayed prescriptions for companies treating ADHD online or have blocked individual prescribers, according to people familiar with the issue.

That was the right outcome as far as the FEHBlog is concerned.

In U.S. Supreme Court news, Business Insurance reports “Private plaintiffs cannot be reimbursed for emotional distress damages under the 1973 Rehabilitation Act and the Patient Protection and Affordable Care Act, the U.S. Supreme Court ruled” last Thursday in the linked opinion. The Affordable Care Act provision at issue is the ACA’s convoluted individual non-discrimination provision, Section 1557.

From the healthcare business front, Fierce Healthcare tells us

Outpatient volumes and revenue for hospitals and health systems showed a robust rebound in March as expenses eased due to fewer extremely sick patients, a new report said. 

Consulting firm Kaufman Hall released its latest hospital flash report Monday (PDF) detailing the impact of system finances for the month of March. A key takeaway from the report is that while actual hospital margins were negative for the third month in a row, outpatient revenues had a massive bump.

“While the road to recovery remains long for many hospitals, these trends indicate some pressures of the pandemic may be lifting,” said Erik Swanson, senior vice president of data and analytics with Kaufman Hall, in a statement. 

From the mental healthcare front,

Fierce Healthcare reports

Mental health concerns are on the rise across the board, and especially among Blacks, seniors, young adults and LGBTQIA people, a new survey finds.

CVS Health and Morning Consult polled more than 2,200 adults in early April and found that 59% of respondents have experienced challenges with their mental health or that of a friend or family member. That is a 9% increase over 2020 survey data.

More than half (57%) of people surveyed who identify as LGBTQIA expressed concern about their own mental health, 20 percentage points higher than other groups included in the study. Nearly three-quarters (74%) of those aged 18 to 34 said they experienced such concerns either themselves or for a friend or family member, up 12 percentage points from 2020.

The survey also found an 11 percentage point increase in mental health concerns among Black respondents compared to pre-COVID levels. A double-digit increase was also found among people over age 65; about 40% reported mental health concerns for themselves or family and friends, up 10 percentage points from 2020.

AHIP describes ten ways that people can get the mental healthcare services that they need.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–

From Capitol Hill, the Senate approved a motion to proceed to a vote on the Postal Reform Act of 2022 (HR 3076) by a voice vote. This vote suggests to the FEHBlog that the Senate will approve the bill this week.

Roll Call discusses the status of the Consolidated Appropriations Act for Fiscal Year 2022. Congress has a week and half to finish cobbling together this law before it needs a fourth continuing resolution.

From the Omicron vaccine front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today released a study examining the effectiveness of the Pfizer COVID-19 vaccine at preventing emergency department and urgent care visits by children aged 5-11 and 12-17. Among children aged 5-11, effectiveness 14-67 days after dose 2 (the longest interval in this age group) was 46%, significantly lower than overall estimates for adolescents aged 12-17. However, most encounters among children aged 5-11 occurred during omicron predominance, when the vaccine’s effectiveness also significantly declined for adolescents, suggesting that the lower effectiveness for children aged 5-11 was likely driven by the predominant variant rather than differences in effectiveness across age groups, the authors said. During omicron predominance, there was no evidence 2 doses protected adolescents after 150 days; however, a booster dose restored effectiveness to 81% in this age group, the authors said.

Another study released today by the CDC looks at reactions to the Pfizer booster in adolescents aged 12-17, which were generally mild to moderate and transient. Myocarditis was less frequently reported after a booster dose than a second primary dose, the authors said.

From the Omicron masking and testing front —

Federal agencies can relax their mask and testing protocols in the wake of new public health guidance. 

The Centers for Disease Control and Prevention’s released on Friday a “new framework” that “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” Dr. Rochelle Walensky, the agency’s director, said on a call with reporters. Guidance from the Biden administration’s Safer Federal Workforce Task Force on Monday reflects this new framework. 

“This document provides federal agencies with initial implementation guidance they should follow in utilizing the CDC’s COVID-19 Community Levels to determine the appropriate mask-wearing and screening testing requirements for each federal facility at a given time,” said the guidance. 

Nearly half of the 500 million free COVID-19 tests the Biden administration recently made available to the public still have not been claimed as virus cases plummet and people feel less urgency to test.

Wild demand swings have been a subplot in the pandemic, from vaccines to hand sanitizer, along with tests. On the first day of the White House test giveaway in January, COVIDtests.gov received over 45 million orders. Now officials say fewer than 100,000 orders a day are coming in for the packages of four free rapid tests per household, delivered by the U.S. Postal Service.

It would be a good idea for the federal government to tell health plans to refer their members to the federal site if they are interested in receiving test kits.

To sum it up from the Omicron front, check out the lead article from the NIH Director’s blog titled “How Covid immunity holds up over time.”

From the tidbits department —

  • The CDC discusses the unholy connection between diabetes and chronic kidney disease.
  • Fierce Healthcare discusses telehealth provider Amwell’s fourth quarter results.
  • Beckers Payer Issues notes

UnitedHealth Group is beginning to act on its November promise to shore up its sustainability efforts by halting its mailing paper of prior authorization and clinical decisions to providers, according to a Feb. 25 post on the California Medical Association website. 

The first move — a nationwide shift to digital clinical decision letters — is effective March 4 for most UnitedHealthcare Medicare Advantage and commercial plan members. Instead of receiving a mail appeal decision, providers can view the decisions digitally immediately after they are made. 

President Joe Biden is calling for more federal employees to return to the office, saying “significant progress” fighting the COVID-19 pandemic has made it safer to do so.

Ahead of his State of the Union address, Biden issued a letter Tuesday thanking the federal workforce for its “tireless work this past year” confronting the pandemic and leading economic recovery efforts.

A return to the office, however, doesn’t necessarily mean a return to the pre-pandemic status quo.

Biden urged agencies to “build on the innovations and technologies that we put to work serving the American people throughout the pandemic, making our government more efficient, resilient, and effective.”

Good luck, OPM.

Weekend Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, OPM, SCOTUS–
Photo by JOSHUA COLEMAN on Unsplash

Both the House and the Senate will be in session this week for Committee business and floor voting. The FEHBlog will be keeping an eye on the House Rules Committee hearing on the Postal Reform Act (HR 3706) scheduled for tomorrow at 2 pm ET.

Roll Call reports

The House could take up a three-week stopgap funding extension through March 11 as soon as Tuesday to buy more time for appropriators to write final fiscal 2022 spending bills, according to sources who spoke on condition of anonymity because details haven’t been made public.

The temporary spending bill under discussion would only move to the floor if an agreement on topline funding allocations for defense and nondefense programs is reached first. But there was enough apparent progress behind the scenes to warrant talk of a short-term extension rather than a longer continuing resolution that could delay needed funds for the Pentagon, infrastructure programs and more. * * *

It wasn’t immediately clear whether the Senate would be on board with a three-week extension, and the length was still under discussion, according to sources. During the weekly House floor colloquy on the chamber’s schedule, [House] Majority Whip James E. Clyburn, D-S.C., wouldn’t comment on timing or specifics but said he hopes it will be a “short, short-term CR” if negotiators can’t write an omnibus before Feb. 18.

From the COVID vaccine front, the Wall Street Journal’s excellent Saturday Essay concerns efforts to extend mRNa vaccines beyond Covid. The FEHBlog just finished reading Wall Street Journal reporter Gregory Zuckerman’s book “A Shot to Save the World” which offers an inside look at the development of the various COVID vaccines. Moderna and BioNTech among other drug manufacturers were working on mRNA vaccines for many years before Covid struck. Their preparation led them to rapidly develop mRNA vaccines against Covid. The BioNTech and Moderna mRNA vaccines against Covid were the first mRNA vaccines approved by the Food and Drug Administration. Researchers in those companies and others now are continuing their work on the development of mRNA vaccines for the flu, cancer, HIV, among other diseases. Hope springs eternal.

The Wall Street Journal also provides an overview of the cases in which federal courts are considering the legality of the Biden administration’s Covid vaccination mandates for federal employees and federal government contractor employees in the wake of two recent U.S. Supreme Court rulings on other vaccine mandates.

Sean Marotta, a partner with law firm Hogan Lovells, said the rulings, taken together, send a message about the federal government’s power: “A vaccine mandate that targets problems specific to a federal regulatory program will likely be upheld. A mandate that is simply an attempt to get as many people vaccinated as possible, or is a workaround for the government not having a general power of vaccination, will probably be struck down

Well put, sir.

From the federal employment front, Federal News Network tells us

The Biden administration wants to give federal employees their largest pay raise in 15 years.

Federal News Network has learned that the White House will propose a 4.6% pay increase for federal employees as part of its fiscal 2023 budget request. The budget request is expected to go to Congress after the State of the Union, which is on March 1,  Shalanda Young, the nominee to be director of the Office of Management and Budget, told the Senate Budget Committee on Feb. 1.